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Pharmaceutical industry

Generex Biotechnology Corp.'s Oral-lyn Demonstrates Favorable Pharmacokinetic Properties in Diabetes Study

Strategic Insights

— 2 min read

Oral-lyn, a proprietary oral insulin spray formulation, has shown promising results in a recent study conducted by a team of diabetes investigators from Hadassah Hebrew University Hospital in Israel. The study, published in the June 2005 issue of Diabetes Care, aimed to evaluate the pharmacodynamic and pharmacokinetic properties of Oral-lyn in comparison with subcutaneous regular insulin. The results demonstrated that Oral-lyn has a faster onset and shorter duration of action compared to subcutaneous insulin, with a dose-response relationship noted in its absorption and metabolic effect.

Key Takeaways:

  • The study was conducted by Professor Itamar Raz, Dr. Simona Cernea, Dr. Miriam Kidron, and Dr. Jay Wohlgelernter from the diabetes unit, department of internal medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel.
  • The study involved 7 healthy volunteers who received 4 different doses of Oral-lyn and 1 dose of subcutaneous regular insulin under euglycemic clamp conditions.
  • The results showed that Oral-lyn has a faster onset and shorter duration of action compared to subcutaneous insulin, with a maximum serum insulin level comparable to subcutaneous insulin at a dose of 20 puffs.
  • The area under the insulin curve (Ins-AUC0-120) and maximum serum insulin levels (Cmax) demonstrated a dose-response relationship for the 3 doses of Oral-lyn (5, 10, and 20 puffs).
  • The study concluded that Oral-lyn is absorbed in direct relation to the amount given and has a faster onset and shorter duration of action compared to subcutaneous regular insulin.
  • The maximum metabolic effect and the amount of glucose infused from 0-120 minutes (GIR-AUC0-120) also increased in a dose-dependent relationship for the 3 doses.

Statistics:

  • 7 healthy volunteers participated in the study.
  • 4 different doses of Oral-lyn (5, 10, and 20 puffs) and 1 dose of subcutaneous regular insulin were administered to the participants.
  • The study demonstrated a dose-response relationship for the 3 doses of Oral-lyn (5, 10, and 20 puffs) in terms of area under the insulin curve (Ins-AUC0-120) and maximum serum insulin levels (Cmax).
  • The area under the insulin curve (Ins-AUC0-120) and maximum serum insulin levels (Cmax) increased by 100-150% compared to subcutaneous insulin at a dose of 20 puffs.

Sources:

  • "Dose-Response Relationship of Oral Insulin Spray in Healthy Subjects." Diabetes Care, Volume 28, Number 6, June 2005, pp. 1353-1357.
  • Health & Medicine Week editors, "Generex Biotechnology Corp.'s Oral-lyn Demonstrates Favorable Pharmacokinetic Properties in Diabetes Study," Health & Medicine Week, 2005.

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